PHILADELPHIA, Jan. 9, 2008 (PRIME NEWSWIRE) -- Hemispherx Biopharma, Inc. (AMEX:HEB) announced today that it has formally submitted to the United States Food & Drug Administration (“FDA”) detailed responses to all of the 14 questions posed by the FDA concerning the Company’s New Drug Application (“NDA”) for Ampligen(r), an experimental therapeutic, to treat Chronic Fatigue Syndrome (“CFS”). Hemispherx received the questions from the FDA on December 5, 2007, at which point the application was deemed by the FDA as “not sufficiently complete” to permit substantive review under 21 CFR 314.101(R). Consequently, the FDA’s consideration of the NDA was postponed, pending receipt of the Company’s answers to the questions.
